1 Mac F/O Laryngoscope recallZ-1288-2022 · Baxter Healthcare Corporation · initiated May 17, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Packaging error.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm issued a recall notification on 05/17/2022 via UPS. The letter instructs the consignee to check their inventory, contact the firm to arrange a return and replacement of mislabeled package, verify contents of all sterile packs are labeled correctly, and complete a response form. Distributors are to share the notification with end users.
Recall details
- Recall number
- Z-1288-2022
- Status
- Terminated
- Initiated by the company
- May 17, 2022
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 99 units
- Product code
- CCW
- Distribution
- Worldwide distribution - US Nationwide and the countries of Japan, Canada, Australia, New Zealand, Spain, Brunei Darussalam, Brazil, India, Colombia, Czechia, Egypt, Turkey, South Africa, Argentina, Mexico, Congo, United Arab Emirates, El Salvador, South Korea, Germany, Cameroon, Guyana, Austria, Bahamas, Bahrain, Bangladesh, Bolivia, Chile, Costa Rica, Dominican Republic, Finland, Guatemala, Honduras, Indonesia, Italy, Kuwait, Libya, Maldives, Namibia, Netherlands, Pakistan, Peru, Philippines, Poland, Saudi Arabia, Trinidad and Tobago, Ukraine, Vietnam.
Product description
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
Code information (models, lots, serial numbers)
Product Codes: 69061 (UDI/DI:732094141382), 69696 (UDI/DI: 732094141078), 69696-LED (UDI/DI: 732094230697); Lot code: 21-056
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Welch Allyn, Inc. 901038Welch Allyn, Inc. · LARYNGOSCOPE, RIGID1 recall0 reports
- Welch Allyn, Inc. 901038Welch Allyn, Inc. · LARYNGOSCOPE, RIGID1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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